This Nutrition industry professional has an advanced degree in nutrition, and several years of experience involving the technical aspects of regulatory affairs, scientific affairs, product labeling, and research & development. His specialties: 21 CFR 101 (Food Labeling), 21 CFR 111 (cGMPs for dietary supplements), FTC advertising guidelines, regulatory compliance review, product substantiation, ingredient research and product development. In his current role as Manager ...
This expert has experience in Medical devices since 1992. Design experience since 1986. Areas of expertise include full life cycle product development of medical devices from conception through development including manufacturing, bench testing, verification, validation, packaging, labeling, clinical trials, regulatory approval, marketing, and sales training. Granted 28 patents (others pending), 7 awards, designs published by Life Magazine, was recognized as one of 100 ...
This industry veteran has been in the consumer products market for 40+ years, including 35 years spent at Amway Corporation. He has been active throughout his career as a scientist and group leader in the development of consumer products, particularly those involving chemical formulations (detergents, cosmetics, cleaners, and others). Since the 1980s, the expert has been active in formal programs that contribute to scientific public policy. He has provided input to ...
This expert has been working in regulatory affairs for nearly 25 years. As a Regulatory Affairs Associate with Bayer Healthcare Pharmaceuticals, he gained significant experience in all facets of drug life cycle, from coordinating, evaluating, and filing submissions for new and marketed products, to responding to Health Canada requests and negotiating with Health Canada scientific reviewers, to preparing and following clinical trial applications. He wrote and revised ...
Since acquiring Monsanto in 2018, lawsuits surrounding the inherited weedkiller, Roundup, have haunted pharmaceutical company, Bayer. Monsanto, an agriculture and biotechnology company, has long been accused of selling a carcinogenic product, with many alleging that the glyphosate in Roundup causes…
In early January 2021, U.S. District Court Judge Robin Rosenberg moved to dismiss economic damages and design defect claims against major drugmakers in the ongoing Zantac multidistrict litigation. Judge Rosenburg ruled that these claims against Sanofi, GlaxoSmithKline, Pfizer, and Boehringer…
A magistrate judge in the Central District of California recently handed down a blockbuster precedent in the product liability case, Kaupelis v. Harbor Freight Tools USA, Inc. The decision concerns the scope of discovery when dealing with personal information protected…
The Federal Trade Commission (FTC) recently issued a record penalty against glue manufacturing company Chemence, Inc. for its violation of a 2016 order to cease deceptive marketing tactics. Now, the company must pay $1.2 million over product labels falsely claiming…
In this product liability case, the court must determine whether the oncology expert witness’s testimony is admissible under the Daubert standard. Specifically, the drugmaker defendant asserts the expert’s opinions on alternate dosing schedules and product labeling oversteps his area of…
Court: United States District Court for the Western District of Missouri, Western Division Jurisdiction: Federal Case Name: Sellers v. Bayer Healthcare Pharms. Inc. Citation: 2016 U.S. Dist. LEXIS 188476 Facts The plaintiff filed a suit against the defendant, a pharmaceutical…
The woman purchased a bottle of over-the-counter Vitamin E supplements manufactured by the defendant pharmaceutical company. After taking several doses of Vitamin E, the woman experienced nausea, stomach cramps, and violent diarrhea, which led to her sudden death. Upon autopsy,…
This case involves a hip implant with package labeling that failed to disclose that it contained a number of cobalt components. The man had undergone surgery to implant the hip, which proceeded without incident. However, shortly after the surgery the…
This case involves a mother in Mississippi who bought a package of small, battery powered toys with multicolored LED illumination. The mother distributed the toys to her own children as well as several of their friends during a birthday party at…
This case involves warning lables that were affixed to a popular antipsychotic medicataion and its generic counterparts. The drug in question was used to treat schizophrenia, as well as a number of other psychiatric disorders, under an established brand name for…
This case takes place in Florida and involves the labeling protocols for a name-brand prescription drug and its generic equivalents. The original drug, developed and marketed over a decade ago, was designed to treat acute episodes of gastrointestinal distress. For…
This case takes place in New York and involves a farmer who was injured while testing a portable irrigation pump. During pressure testing, the pipe was attached to the pumping apparatus and was filled to a few hundred pounds of…
This case takes place in Colorado and involves patient who underwent a hysterectomy using a Da Vinci Surgical System. The patient suffered thermal rectal burn/perforation that was unrecognized during the procedure. She subsequently developed a range of issues, necessitating multiple corrective…
